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Trial record 6 of 6 for:    "Brain Injury" | "Epinephrine"

Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT04074265
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Rachel Thompson, MD, University of California, Los Angeles

Brief Summary:

Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. Adequate pain control after surgery is pivotal for these patients in order to prevent negative physiologic and psychologic complications and to improve surgical outcomes. There is an ongoing shift away from the use of opioids in the post-operative setting due to both their negative side effects and their high potential for dependence and abuse.

A variety of new techniques of multimodal pain management have been developed and utilized in elective orthopaedic procedures. Injection of local anesthetics is becoming a widely popular technique utilized in adult arthroplasty. This technique blocks pain directly at the site of injection, and therefore can improve post-operative pain while minimizing side effects. Evidence has demonstrated this technique to be both safe and effective, resulting in reduced opioid consumption post-operatively. However, this technique has not been studied for use in pediatric patients, a population in which reduced narcotic use is equally, if not more important than in adult patients.

This study is a prospective, randomized controlled trial with 2 parallel arms. The goal of this study is to assess the efficacy of a surgical-site pain injection administered in pediatric patients with cerebral palsy undergoing major hip surgery. Patients who are scheduled to undergo surgery will be randomized to either intervention (injection of a pain cocktail) or placebo (injection of normal saline). The pain cocktail includes three medications: ropivacaine (a local anesthetic), ketorolac (an anti-inflammatory medication), and epinephrine (a medication to constrict blood vessels and increase the duration of action of any co-administered medications). A surgeon who is blinded to treatment group will administer the injection at the end of the procedure, prior to the patient waking from anesthesia. The injection is in addition to our typical multi-modal pain control protocol, which includes epidural anesthesia, acetaminophen, anti-inflammatories, oral narcotics and anti-spasmodic agents. Patients will then be monitored post-operatively and pain medication consumption (both while in the hospital post-operatively and for the first two weeks following discharge), patient-reported and/or nurse-recorded pain scores, length of hospital stay, and adverse effects will be recorded. At the first post-operative visit, patients' parents will be asked to complete a survey designed to assess parent satisfaction with their child's pain management after surgery. Patients, parents, and surgeons will be blinded to treatment group allocation. Data will be collected while the patient is in the hospital, after surgery (average duration 3-4 days), and at the first post-operative visit two to three weeks after surgery.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Hip Dysplasia Pain, Postoperative Drug: Ropivacaine injection Drug: normal saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to either treatment/intervention group or placebo. All other aspects of care will be identical between the two groups.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Surgeon, participant, and all nursing staff involved in recording post-operative outcomes will be blinded to treatment group allocation.
Primary Purpose: Treatment
Official Title: Efficacy of a Peri-Operative Surgical-Site, Multimodal Drug Injection in Pediatric Patients With Cerebral Palsy Undergoing Hip Surgery: A Randomized Controlled Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pain injection
This group will be injected with a cocktail totaling 40mL (20mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Drug: Ropivacaine injection
Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
Other Names:
  • ropivacaine
  • ketorolac
  • epinephrine

Placebo Comparator: Normal saline
The control group will receive an injection of 40mL of 0.9% sodium chloride solution.
Drug: normal saline
Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: During initial post-operative hospitalization (estimated 3-4 days) ]
    Average post-operative opioid consumption, measured in morphine equivalents per kilogram


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Expected 3-4 days ]
    Post-operative hospital length of stay

  2. Post-operative pain scores [ Time Frame: Expected 3-4 days ]
    Pain score assessments will be completed in the post-anesthesia care unit, and every 4 hours following the surgical procedure. Scores will be collected by nursing staff on the inpatient ward who are blinded to treatment allocation and recorded in the electronic medical record. The type of pain score collection will vary based on patient age and level of intellectual disability. In verbal children, either the visual analog scale (VAS) or faces pain scale will be employed. In non-verbal children, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be employed. All three scales measure a patient's pain on a scale of zero (no pain) to ten (the worst pain). Lower values are considered better than higher values. These scores will be combined into an average score for the hospitalization. A higher average score indicates more pain (worse outcome), while a lower average score indicates less pain (better outcome).

  3. Parent satisfaction [ Time Frame: 2-3 weeks post-operatively ]
    Parent satisfaction will be based on a standardized, validated questionnaire taken by parents in person at the first post-operative clinic visit aimed to assess their satisfaction with their child's pain management peri-operatively. Each question is answered with a score of either 1-5, with 1 being the best outcome and 5 being the worst outcome. The score for each question will be summed together to come up with a total score. A higher total score indicates a worse level of satisfaction with perioperative pain management.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • under 18 years old
  • diagnosis of cerebral palsy
  • undergoing uni- or bilateral proximal femoral osteotomy

Exclusion Criteria:

  • ongoing preoperative opioid use
  • history of allergic reaction to any component of the pain injection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074265


Contacts
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Contact: Danielle E Greig, MD 6263545297 dgreig@mednet.ucla.edu
Contact: Sierra Pinal sierra.pinal@gmail.com

Locations
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United States, California
Orthopaedic Institute for Children Not yet recruiting
Los Angeles, California, United States, 90007
Contact: Rachel M Thompson, MD       rathompson@mednet.ucla.edu   
Contact: Danielle E Greig, MD    6263545297    dgreig@mednet.ucla.edu   
Principal Investigator: Rachel M Thompson, MD         
Sub-Investigator: Danielle E Greig, MD         
Ronald Reagan UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Rachel M Thompson, MD       rathompson@mednet.ucla.edu   
Contact: Danielle E Greig, MD    6263545297    dgreig@mednet.ucla.edu   
Principal Investigator: Rachel M Thompson, MD         
Sub-Investigator: Danielle E Greig, MD         
UCLA Medical Center, Santa Monica Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Rachel M Thompson, MD       rathompson@mednet.ucla.edu   
Contact: Danielle E Greig, MD    6263545297    dgreig@mednet.ucla.edu   
Principal Investigator: Rachel M Thompson, MD         
Sub-Investigator: Danielle E Greig, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Vineeta Swaroop, MD       vtswaroop@luriechildrens.org   
Contact: Jill Larson, MD       jillson101@gmail.com   
Principal Investigator: Vineeta Swaroop, MD         
Sub-Investigator: Jill Larson, MD         
Sponsors and Collaborators
University of California, Los Angeles
Northwestern University
Investigators
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Principal Investigator: Rachel M Thompson, MD University of California, Los Angeles

Publications:

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Responsible Party: Rachel Thompson, MD, Associate Director, Center for Cerebral Palsy, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04074265     History of Changes
Other Study ID Numbers: 19-001423
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rachel Thompson, MD, University of California, Los Angeles:
cerebral palsy
randomized controlled trial
pediatric
pain management
perioperative medicine
Additional relevant MeSH terms:
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Brain Damage, Chronic
Epinephrine
Hip Dislocation
Hip Dislocation, Congenital
Paralysis
Cerebral Palsy
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Postoperative Complications
Pathologic Processes
Pain
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Ketorolac
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents